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FDA 510(k)

GDLH POSTERIOR SPINAL SYSTEM

K-Number: K950596 · 1995-08-28

ApplicantSofamor Danek USA,Inc.
Decision Date1995-08-28
Product CodeMNH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

GDLH POSTERIOR SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sofamor Danek USA,Inc.. It received FDA 510(k) clearance on 1995-08-28 under 510(k) number K950596. The device is classified under product code MNH. It was reviewed by the OR advisory panel. Product code MNH falls under the category of ENT, which includes ear, nose, and throat diagnostic and surgical devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the GDLH POSTERIOR SPINAL SYSTEM?

GDLH POSTERIOR SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Sofamor Danek USA,Inc.. The 510(k) number is K950596.

When did GDLH POSTERIOR SPINAL SYSTEM receive FDA 510(k) clearance?

GDLH POSTERIOR SPINAL SYSTEM received FDA 510(k) clearance on 1995-08-28, under 510(k) number K950596.

Who is the listed applicant for GDLH POSTERIOR SPINAL SYSTEM?

The FDA 510(k) record lists Sofamor Danek USA,Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GDLH POSTERIOR SPINAL SYSTEM?

The FDA product code for GDLH POSTERIOR SPINAL SYSTEM is MNH. This falls under the ENT category.

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Other records listing Sofamor Danek USA,Inc. as applicant

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Related Devices (Code: MNH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162066Reliance Spinal Screw SystemReliance Medical Systems, LLCK162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd.K162143FixxSure® X-LinkInnovasis, Inc.K161151Spinal fixation systemCanwell Medical Co., Ltd.K162189ANAX™ 5.5 Spinal SystemU&I CorporationK151362HC Spinal SystemHung Chun Bio-S Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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